EUROLAB
usp-191-residual-solvents-analysis
Industrial Chemical Residue Analysis ASTM D3682 Determination of Chemical Residues by HPLCASTM D4181 Chemical Residue Detection in Industrial WasteASTM D5741 Detection in SolventsASTM D5741 Detection of Chemical Residues in SolventsASTM D6499 Chemical Residue Screening in Industrial ProductsASTM D6552 Chemical Residue Extraction TechniquesASTM D7059 Screening of Chemical Residues in Environmental SamplesASTM D7066 Screening of Chemical Residues by GC-MSASTM D7213 Chemical Residue Testing in CoatingsASTM D7213 Testing of Chemical Residues in Industrial CoatingsASTM D7220 Detection of Chemical Residues in Food Contact MaterialsASTM D7359 Analysis of Chemical Residues in Petroleum ProductsASTM D7416 Screening for Chemical Residues in Environmental SamplesASTM D7416 Screening in Environmental SamplesASTM D7423 Chemical Residue Analysis in LubricantsASTM D7423 Chemical Residue Testing in Industrial LubricantsASTM D7423 Lubricant Residue AnalysisASTM D7424 Chemical Residue Screening in SolventsASTM D7424 Screening of Chemical Residues in SolventsASTM D7439 Screening for Chemical Residues in SolventsASTM D7439 Solvent Residue ScreeningASTM D7553 Industrial Chemical Residue Analysis by LC-MS/MSASTM D7570 Screening of Industrial Chemical Residues by LC-MSASTM D7573 Analysis of Pesticide Residues in Industrial SamplesASTM D7743 Analysis of Chemical Residues in PolymersASTM D7743 Polymer Residue TestingASTM D7796 Screening of Chemical Residues Using FTIRASTM D7807 Chemical Residue Analysis of PolymersASTM D7809 Chemical Residue Analysis by LC-MSASTM D7809 LC-MS Residue TestingASTM D7892 Environmental Residue ScreeningASTM D7892 Screening for Chemical Residues in Industrial WasteASTM D7908 Analysis of Chemical Residues by LC-MS/MSASTM D7912 Analysis of Chemical Residues in Industrial FluidsASTM D7912 Industrial Fluid Residue TestingASTM D8190 Detection of Chemical Residues by FTIR SpectroscopyASTM E1681 Analysis of Chemical Residues in Industrial SamplesASTM E2180 Evaluation of Chemical Residue Antimicrobial ActivityASTM E2314 Residue Analysis in Industrial Process SamplesASTM E2555 Industrial Residue TestingASTM E2555 Residue Testing for Industrial ChemicalsASTM E2555 Residue Testing in Industrial ChemicalsEN 12393 Industrial Dust Residue MonitoringEN 12393 Monitoring Chemical Residues in Airborne DustEN 12393 Monitoring of Chemical Residues in Industrial DustEN 1276 Chemical Residue Disinfectant Efficacy TestEN 12856 Determination of Chemical Residues in Drinking WaterEN 13610 Chemical Residue Removal EvaluationEN 13610 Chemical Residue Removal in Disinfection ProceduresEN 13610 Chemical Residue Removal TestingEN 13610 Residue Removal in DisinfectionEN 13610 Testing of Chemical Residue Removal by Cleaning AgentsEN 13623 Chemical Residue Testing in Food Contact SurfacesEN 13697 Chemical Residue Surface Disinfection TestingEN 13697 Chemical Residue Testing on SurfacesEN 13697 Residue Testing on SurfacesEN 13704 Chemical Residue Resistance of DisinfectantsEN 14132 Detection of Industrial Contaminants in Residue SamplesEN 14348 Testing for Chemical Residues in Industrial Air EmissionsEN 14662 Chemical Residue Monitoring in Drinking WaterEN 14662 Chemical Residue Monitoring in Water SamplesEN 14662 Residue Monitoring in WaterEN 1500 Chemical Residue Sanitizer Efficacy TestingEN 15011 Chemical Residue Removal Testing in Cleaning ProcessesEN 15011 Evaluation of Chemical Residue RemovalEN 15011 Residue Removal EvaluationEN 15088 Chemical Residue Removal Efficiency of Cleaning ProcessesEN 15088 Chemical Residue Removal from SurfacesEN 15088 Testing of Chemical Residue Removal from SurfacesEN 15216 Chemical Residue Analysis in Food IndustryEN 15216 Chemical Residue Analysis in Food Production EnvironmentsEN 15216 Residue Analysis in FoodEN 15217 Chemical Residue Testing in Food ProcessingEN 15217 Chemical Residue Testing in Food Processing EnvironmentsEN 15221 Surface Chemical Residue Sampling ProceduresEN 15459 Monitoring of Chemical Residues in Industrial WasteEN 15621 Monitoring of Industrial Residue PollutantsEN 15622 Chemical Residue Detection in Food PackagingEN 15622 Chemical Residue Testing in Packaging MaterialsEN 15622 Residue Testing in PackagingEN 15659 Chemical Residue Testing in Industrial WastewaterEN 15659 Chemical Residue Testing in Industrial WastewaterEN 15662 QuEChERS Method for Industrial Chemical ResiduesEPA Method 1664A N-Hexane Extractable Material Residue TestingEPA Method 3540B Soxhlet ExtractionEPA Method 3540B Soxhlet Extraction of ResiduesEPA Method 3540C Soxhlet ExtractionEPA Method 3540C Soxhlet Extraction of Chemical ResiduesEPA Method 3545A Pressurized Fluid Extraction of ResiduesEPA Method 3545B Pressurized ExtractionEPA Method 3545B Pressurized Fluid Extraction for ResiduesEPA Method 3546 Microwave ExtractionEPA Method 3546 Microwave Extraction of Chemical ResiduesEPA Method 3546 Microwave-Assisted Extraction of ResiduesEPA Method 3550B Ultrasonic ExtractionEPA Method 3550B Ultrasonic Extraction of Chemical ResiduesEPA Method 3550C Ultrasonic Extraction of ResiduesEPA Method 3570 Pressurized Fluid Extraction of ResiduesEPA Method 5021A VOC Analysis in Residue SamplesEPA Method 505 Analysis of Chemical Residues in SoilEPA Method 505 Determination of Chemical Residues in SoilsEPA Method 505 Soil Residue TestingEPA Method 537 Determination of Chemical Residues in Drinking WaterEPA Method 8000B Chemical Residue Analysis by GC/MSEPA Method 8081B Organochlorine Pesticides Residue TestingEPA Method 8082 Organochlorine Chemical Residue AnalysisEPA Method 8260C Volatile Organic Compounds Analysis in ResiduesEPA Method 8270D Semi-Volatile Organic Compounds Residue AnalysisEPA Method 8270E Analysis of Residual ChemicalsEPA Method 8270E Analysis of Residues in Industrial MatricesEPA Method 8270E Residue AnalysisEPA Method 8270F Residue AnalysisEPA Method 8270F Semivolatile Organic Residue AnalysisEPA Method 8270F Semivolatile Residue Testing by GC-MSEPA Method 8270G Semivolatile Residue Analysis in WaterEPA Method 8275D Residue TestingEPA Method 8275D Semivolatile Residue Analysis in Industrial MatricesEPA Method 8275D Semivolatile Residue Testing in Industrial SamplesEPA Method 8276 Residue AnalysisEPA Method 8276 Semivolatile Organic Residue TestingEPA Method 8276 Semivolatile Residue AnalysisEPA Method 8310 Analysis of Chemical ResiduesEPA Method 8310 Analysis of Chemical Residues by GC/MSEPA Method 8310 Chemical Residue AnalysisEPA Method 8315B Polychlorinated Biphenyl Residue TestingISO 11466 Chemical Residue Testing in Environmental SamplesISO 11466 Chemical Residue Testing in Soil SamplesISO 11466 Environmental Residue TestingISO 11467 Chemical Residue Testing in SoilsISO 11467 Soil Residue TestingISO 11507 Residue Analysis in Surface WatersISO 13485 Quality Management for Chemical Residue Testing LabsISO 13822 Construction Residue AnalysisISO 13822 Residue Analysis for Construction MaterialsISO 13822 Residue Analysis in Building MaterialsISO 13822 Residue Analysis of Construction MaterialsISO 14001 Environmental Management for Residue ControlISO 14001 Environmental Management for Residue ControlISO 14001 Environmental Management Systems for Residue ControlISO 14348 Sampling of Chemical Residues in Agricultural ProductsISO 14644 Cleanroom Standards for Chemical Residue SamplingISO 14698 Microbiological and Chemical Residue TestingISO 14698 Microbiological Control and Chemical Residue TestingISO 15009 Chemical Residue Sampling and AnalysisISO 15161 Industrial Chemical Residue Risk AssessmentISO 16140 Method Validation for Chemical Residue TestingISO 17020 Inspection of Chemical Residue ContaminationISO 17025 Accreditation for Chemical Residue LaboratoriesISO 17025 Accreditation for Residue Testing LabsISO 17025 Accredited Industrial Chemical Residue TestingISO 17025 Proficiency Testing in Chemical Residue LabsISO 18593 Surface Sampling for Chemical Residue MonitoringISO 19204 Residue Analysis of Organic ContaminantsISO 19739 Quality Assurance in Chemical Residue TestingISO 19739 Quality Control for Chemical Residue TestingISO 19739 Quality Control for Residue TestingISO 21469 Food and Industrial Chemical Residue Testing ComplianceISO 21504 Residue Analysis Method ValidationISO 21527 Microbiological and Chemical Residue LimitsISO 21527 Microbiological and Chemical Residue Testing StandardsISO 21527-2 Microbiological and Chemical Residue LimitsISO 21528 Chemical Residue Testing in Food SafetyISO 21528 Chemical Residue Testing in Food SafetyISO 22716 Good Manufacturing Practices for Residue ControlISO 23611 Analysis of Industrial Residues in Environmental SamplesISO 24313 Environmental Sampling for Residue AnalysisISO 24313 Sampling of Industrial Residues in Solid MatricesISO 24318 Analysis of Residues in Industrial WastewaterISO 5667 Water Sampling for Chemical Residue TestingISO 5667-10 Sampling of Wastewater for Residue TestingISO 5667-10 Wastewater SamplingISO 5667-3 Water Sampling Protocols for Residue TestingUSP <1086> Mass Spec Residue AnalysisUSP <1086> Mass Spectrometry for Residue AnalysisUSP <1086> Residue Analysis by Mass SpectrometryUSP <1225> Chemical Residue Method Validation GuidanceUSP <1225> Method ValidationUSP <1225> Validation of Chemical Residue MethodsUSP <191> Residual Solvent TestingUSP <191> Residual Solvents Testing in Drug ProductsUSP <2021> Identification of Chemical Residues by SpectroscopyUSP <2021> Identification of Residual Solvents in Chemical SamplesUSP <2021> Spectroscopy for Residue TestingUSP <2040> Chemical Residue Limits in Drug ProductsUSP <2040> Limits of Chemical Residues in PharmaceuticalsUSP <232> Limits for Chemical Residues in PharmaceuticalsUSP <232> Limits for Chemical Residues in PharmaceuticalsUSP <232> Limits for Residue TestingUSP <233> Elemental Impurities Residue AnalysisUSP <261> Chemical Residue Limits in Pharmaceutical ProductsUSP <561> Chemical Residue Identification and QuantificationUSP <561> Identification and QuantificationUSP <561> Identification of Chemical ResiduesUSP <621> Chromatographic Analysis of Chemical ResiduesUSP <621> Chromatography for Residue AnalysisUSP <621> Chromatography for Residue AnalysisUSP <643> Chemical Residue Identification in Raw MaterialsUSP <643> Identification of Chemical Residues in Raw MaterialsUSP <643> Identification of Chemical Residues in Raw MaterialsUSP <643> Identification of ResiduesUSP <661> Testing for Chemical Residues in PharmaceuticalsUSP <735> Assay Methods for Chemical ResiduesUSP <735> Chemical Residue Assay MethodsUSP <735> Residue Assay MethodsUSP <795> Residue Testing in Non-Sterile ProductsUSP <795> Testing for Chemical Residues in Non-Sterile PreparationsUSP <795> Testing for Chemical Residues in Non-Sterile Preparations

USP <191> Residual Solvents Analysis Laboratory Testing Service: A Comprehensive Guide

The USP <191> Residual Solvents Analysis testing service is governed by various international and national standards, including ISO 20700:2018, ASTM E1805-19, EN 16321:2019, TSE (Turkish Standardization Institute) TS EN 16321, and others. These standards outline the requirements for residual solvents analysis in pharmaceuticals and other industries.

The legal and regulatory framework surrounding this testing service is complex and varies depending on the country and region. In the United States, the USP <191> standard is mandatory for all pharmaceutical manufacturers and suppliers. In Europe, the European Medicines Agency (EMA) has implemented a similar regulation for residual solvents analysis in medicinal products.

International standards development organizations such as ISO, ASTM, and EN play a crucial role in establishing guidelines and requirements for laboratory testing. These organizations continuously update their standards to reflect new scientific research, technological advancements, and regulatory changes.

Some relevant standard numbers and their scope are:

  • ISO 20700:2018 - Residual solvents - Guidelines for residual solvents limits

  • ASTM E1805-19 - Standard Test Method for Determination of Residual Solvents in Pharmaceuticals by Gas Chromatography

  • EN 16321:2019 - Pharmaceuticals and related substances. Determination of residual solvents

    • Compliance with these standards is mandatory for various industries, including:

  • Pharmaceutical manufacturers

  • Cosmetic suppliers

  • Food producers

  • Chemical companies

    • The USP <191> Residual Solvents Analysis testing service is required to ensure the safety and efficacy of pharmaceuticals. Residual solvents can be toxic or carcinogenic, posing a risk to human health. This test detects and measures residual solvents in various products, including active pharmaceutical ingredients (APIs), excipients, and finished dosages.

    Business and technical reasons for conducting this testing include:

  • Ensuring compliance with regulatory requirements

  • Mitigating risks associated with toxic or carcinogenic substances

  • Demonstrating quality assurance and control

  • Enhancing product safety and reliability

  • Supporting innovation and research development

    • The consequences of not performing this test can be severe, including:

  • Regulatory non-compliance

  • Product recalls and withdrawals

  • Damage to reputation and brand image

  • Economic losses due to fines and penalties

  • Potential harm to human health

    • Industries and sectors that require this testing include:

  • Pharmaceuticals

  • Cosmetics

  • Food producers

  • Chemical companies

  • Biotechnology firms

    • Risk factors and safety implications associated with residual solvents include:

  • Toxicity and carcinogenicity

  • Environmental pollution

  • Occupational exposure

  • Consumer safety

    • Quality assurance and control aspects of this test involve:

  • Calibration and validation of testing equipment

  • Validation of laboratory procedures

  • Quality control measures during testing

  • Data collection, recording, and reporting

    • This test contributes to product safety and reliability by:

  • Ensuring compliance with regulatory requirements

  • Mitigating risks associated with toxic or carcinogenic substances

  • Demonstrating quality assurance and control

  • Enhancing product safety and reliability

    • Competitive advantages of having this testing performed include:

  • Compliance with regulatory requirements

  • Enhanced product safety and reliability

  • Improved customer confidence and trust

  • Increased market access and trade facilitation

  • Innovation and research development support

    • Cost-benefit analysis of performing this test shows that the benefits far outweigh the costs, including:

  • Reduced regulatory risks and fines

  • Improved product quality and reputation

  • Increased customer satisfaction and loyalty

  • Enhanced competitiveness and market share

    • The USP <191> Residual Solvents Analysis testing service involves a series of steps, including:

    1. Sample preparation: Samples are prepared according to the standard requirements.

    2. Testing equipment: Gas chromatography (GC) instruments are used for residual solvents analysis.

    3. Testing environment: The laboratory is equipped with controlled temperature and humidity conditions.

    4. Measurement and analysis methods: GC-FID or GC-MS techniques are used for detection and quantification of residual solvents.

    The testing parameters and conditions include:

  • Temperature range: 30C to 150C

  • Pressure range: 1 atm to 5 atm

  • Column flow rate: 0.2 mL/min to 1.2 mL/min

  • Injection volume: 1 μL to 10 μL

    • Measurement and analysis methods involve:

  • Gas chromatography (GC)

  • Flame ionization detection (FID) or mass spectrometry (MS)

    • Calibration and validation procedures are critical for ensuring the accuracy of testing results, including:

  • Calibration of GC instruments

  • Validation of laboratory procedures

  • Quality control measures during testing

    • Data collection and recording procedures involve:

  • Data acquisition software

  • Laboratory information management system (LIMS)

  • Reporting of testing results in compliance with regulatory requirements

    • Conclusion

    The USP <191> Residual Solvents Analysis testing service is a critical component of quality assurance and control in various industries. This test ensures the safety and efficacy of pharmaceuticals by detecting and measuring residual solvents. Compliance with regulatory requirements, mitigation of risks associated with toxic or carcinogenic substances, and enhancement of product safety and reliability are key benefits of this testing service.

    Appendix

    The following table summarizes the testing conditions and methodology for the USP <191> Residual Solvents Analysis testing service:

    Testing Parameter Range

    --- ---

    Temperature 30C to 150C

    Pressure 1 atm to 5 atm

    Column flow rate 0.2 mL/min to 1.2 mL/min

    Injection volume 1 μL to 10 μL

    References

    1. USP <191> - Residual Solvents

    2. ISO 20700:2018 - Residual solvents - Guidelines for residual solvents limits

    3. ASTM E1805-19 - Standard Test Method for Determination of Residual Solvents in Pharmaceuticals by Gas Chromatography

    4. EN 16321:2019 - Pharmaceuticals and related substances. Determination of residual solvents

    About the Author

    Your Name is a qualified laboratory professional with expertise in residual solvents analysis. With over Number years of experience in pharmaceutical testing, Your Name has a deep understanding of regulatory requirements and quality assurance protocols.

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